Process Assessment and Improvement Approach

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1 Process Assessment and Improvement Approach June 2008 The information contained in this document represents the current view of Virtify on the issues discussed as of the date of publication. Virtify cannot guarantee the accuracy of any information presented after the date of publication. This document is for informational purposes only. Virtify makes no warranties, express or implied, as to the information in this document. Complying with all applicable copyright laws is the responsibility of the user. Virtify may have patents, patent applications, trademarks, copyrights, or other intellectual property rights covering subject matter in this document. Except as expressly provided in any written license agreement from Virtify, the furnishing of this document does not give you any license to these patents, trademarks, copyrights, or other intellectual property. Page 1 of 9

2 1. Background Business operations managers constantly need to assess, fine tune and optimize their organizational processes with an eye towards streamlined operations. The challenge lies in balancing these process improvements while minimally disrupting day-to-day operations. Further, the process optimization need to account for rapidly changing business needs, current and upcoming regulatory changes (e.g., ectd, Structured Product Labeling, estability etc.), evolving technology and infrastructure. In addition, involvement and continuous engagement of key stakeholders is often a key challenge. We recommend a phased process assessment and improvement methodology that offers a comprehensive review and assessment of the efficiency and effectiveness of the organization s current processes and results in practical recommendations for quick-hit and long-term strategic process improvements to suit specific organizational needs. Such improvements can result in more streamlined processes that provide better predictability and consistency in operational results, improved control over both the process and associated costs, and finally, a deeper insight into the strategic value of process improvement. 2. Process Assessment and Improvement Methodology Virtify uses a structured process assessment and improvement methodology to enable organization to streamline their operations. This methodology is: A quality-driven process based on an integrated set of deliverables that build on each other incrementally to deliver solutions quickly. It is flexible enough to consider each clientʹs specifics without sacrificing a rigorous quality framework. Based on the notion that a process is the collection of activities that transform inputs into outputs to achieve organizational objectives. Based on the recognition that there are two types of processes: core processes that deliver value directly to key customers or stakeholders, and support processes that support the core processes. Focused on the key components of assessing and improving a process, namely Define, Measure, Analyze, Improve and Control. These components and their interconnections are shown in Figure 1, and form the core of the phased project approach outlined below. Page 2 of 9

3 2.1 Process Assessment and Improvement Steps Essential elements of the Process Assessment and Improvement include the following steps: 1. DEFINE: This step involves defining the problem (or area of focus), articulating the current process, and identifying key stakeholders involved in the process. 2. MEASURE: In this step, we identify what is being measured and a key element of this step is the identification of the appropriate benchmarks (industry and other internal/external benchmarks) against which the process is being compared. 3. ANALYZE: The next step involves analysis of the process under consideration for root cause or trend analysis. 4. IMPROVE: Upon completion of the analysis of the process, the next step is to a) identify solutions that enable process improvement and b) establish criteria for testing the solution. In addition, another key element of this step is the definition of the roadmap for implementing the identified solution. 5. CONTROL: This step focuses on establishing the appropriate mechanisms to ensure a successful implementation of the improved process. Elements include (re) training, documentation, continuous testing, expectation/communication management and rollout to the organization. Once these process improvement steps have been completed, we recommend continuous monitoring and calibration against benchmarks to ensure ongoing fine tuning and periodic improvements. Essentially, the lifecycle of the steps listed above should be repeated as and when appropriate and necessary. 2.2 Implementation Approach The process assessment and improvement methodology listed in Section 2.1 can be implemented within a broader, phased approach consisting of the Requirements Gathering, Process Mapping, Process Analysis, Process Redesign, and Roadmap Generation phases will be used within a structured project management framework to develop the project deliverables. Such a phased approach, including the use of the process assessment components outlined in Figure 1, is illustrated below in Figure 2. Page 3 of 9

4 CONTROL Are people prepared and is the documentation complete? Are measures identified and is there an ongoing monitoring process? Has the process been error-proofed? Start DEFINE What is the problem? What is the process? What is the focus? Who are the key customers and stakeholders? MEASURE What are the steps of the process? What will be measured? What is the target with respect to process effectiveness, process efficiency and process adaptability? IMPROVE What is the best solution? How should it be tested? How should it be implemented? ANALYZE What patterns or trends emerge? What is the potential root cause? Figure 1: The various components of process assessment and improvement are shown in this figure. The assessment begins with a Define phase focusing on the people, problem and process, followed by a Measure phase that examines the various steps in the process and related measurement criteria. The Measure phase is followed by the Analyze phase that aims to come up with gaps in the current process and the root cause for the gaps. The Improve phase identifies the redesigned process and its implementation criteria, followed by a Control phase for continuous monitoring and management of the redesigned process. These components are used iteratively. [Rest of page left intentionally blank.] Page 4 of 9

5 Requirements Gathering Current Process Mapping Current Process Analysis Process Redesign Roadmap Generation Implementation Define Measure Improve Control Analyze Define Figure 2: This figure illustrates the various phases of Virtify s methodology for process improvement. The accompanying components of process assessment are overlaid (in italics) on the various phases of the project. In the context of this phased approach for process assessment and improvement, we recommend a team consisting of relevant domain experts, along with key organization stakeholders, to work in a tightly integrated project team to: 1. Conduct a project kickoff meeting for project planning, scheduling and identifying administrative issues. 2. Generate business requirements using facilitated workshop and interview sessions with representative cross-functional end user groups. We recommend a series of facilitated discussions with relevant cross-functional end user groups to obtain this information. These discussions should be staggered to allow for the most efficient use of time and reduce the amount of follow-up effort. Often, it may be necessary to meet with organization personnel outside of the core groups to gather the data required. The sessions should focus on gathering information about the current process, systems and applications, flow of data/content, immediate and long-term use of the data, and impact on relevant organizational operations. The information gathered from this phase should be used to perform the process assessment, estimate organizational impacts and to build the roadmap in subsequent phases of the project. 3. Identify and map the business process flows of the current document creation, document storage, submission preparation, assembly and publication processes. These business process flows include responsible individuals or organizations, relevant SOPs, Page 5 of 9

6 templates and tools used, and metrics. The relationships between people, functions and process steps should be illustrated via crossfunctional process maps. 4. Perform a current process assessment and gap analysis based on the prioritized business requirements and the process maps generated in the previous phase. Current and desired measures for various aspects of the process (e.g., number of review cycles of the content, time taken to format and assemble the submission, quality of the content etc.) should be used in assessing the deficiencies of the current process and identifying target performance goals. 5. Develop a redesigned process to address process gaps and enable optimal future document creation, document storage, submission preparation, assembly and publication processes. During the redesign phase, specific attention will be paid to factors related to the improved process (e.g., assembling an electronic submission, the structure, including electronic review aids, of the application, file naming conventions, generation of XML backbones, and related ectd factors. Global regulatory requirements for paper submissions (e.g., in the EU) should also be taken into account during the redesign phase.) In addition, a high-level organizational impact assessment of the proposed solution should be performed, including roles and responsibilities of the organizations and functions involved in the solution, business process changes necessitated by the proposed solution, and impact of business process changes on available personnel and responsibilities. 6. Finalize a roadmap for the process improvement. The roadmap should include all tasks, estimated durations, responsible individuals and skill sets for implementing the recommendations. We recommend the following deliverables be developed as part of the project: 1. Detailed business process flows (e.g., current document creation, document storage, submission preparation, assembly and publication processes). These business process flows should include responsible individuals or organizations, relevant SOPs, tools used, and metrics. The areas of risk should also be identified in these process flows. Page 6 of 9

7 2. A detailed roadmap for moving organization s business processes to support the new process (e.g., ectd-based submissions). This roadmap should include all strategic and tactical aspects of implementing the required business processes. The roadmap should also include all tasks, estimated durations, responsible individuals and skill sets. 3. Critical Success Factors and Common Pitfalls The following critical success factors will enable a successful application of the proposed approach and methodology towards streamlining operations. Common pitfalls of traditional process assessments exercises are also included in the following subsections. 3.1 Value Driven A key critical success factor is a clear, documented understanding of the business requirements that drive the process being assessed. All technology decisions related to the process, should be made based on the business requirements. The intent is not to implement technology for technology s sake. The project approach and methodology are structured to understand the relationships between market factors, business strategies, performance measures, workflows, and enabling technologies. These relationships rank the business initiatives and develop the implementation roadmap. 3.2 Cross-functional Teams and Common Understanding of Goals Virtify defines the cross-functional team as a group with even representation from the business, user, and technical communities. Team members must be dedicated to the project, have a common understanding of the goals of the project, be empowered to make decisions, and be involved for the duration of the project to maximize the effectiveness of the cross-functional team. Timely access to an appropriate cross-functional team is a key success factor. 3.3 Managing the Scope of Process Mapping The purpose of process mapping is to develop a common understanding of the business requirements impacting the process. Many process assessment projects get derailed due to the analysis-paralysis syndrome Page 7 of 9

8 and inordinate documentation of exceptions to the general process. It is critical to monitor the process mapping exercise to ensure that this pitfall is avoided. Thus, effective management of scope is a critical success factor. 3.4 Communication and Expectation Management Another key critical success factor in the successful implementation of the project is the clear communication of project roles, goals and expectations to the appropriate stakeholders and affiliated personnel. It is important to work with relevant internal and external organizations to establish appropriate communication mechanisms and to ensure that the appropriate expectations are set proactively. 3.5 Integrated Project Management and Proactive Risk Management Project management is the application of knowledge, skills, tools, and techniques to project activities in order to meet or exceed stakeholder expectations. The focus of project management is on getting people to complete a series of tasks aimed at a final deliverable, through: A high degree of review. The establishment of a project culture that enforces an environment of raising and escalating issues as early as possible. The ability to effectively manage issues and change as the project progresses. We recommend employing proven, disciplined methodology and best practices around project management, based on an experienced staff that has developed and refined these practices over many years and complex projects. Such a project management methodology allows for closely tracking and managing the cost, scope and schedule of the project. In addition, process rigor and discipline within the methodology ensure the delivery of high quality results on time and within budget. For example, Virtify works closely with the relevant Organization stakeholders to develop and manage communication, risk, project controls, and best practices. The key project management phases, with project communication being a vital component of all the phases, include: Cost and Schedule Tracking and Management: Throughout the lifecycle of a project, Virtify s approach ensures close tracking and Page 8 of 9

9 4. Conclusions management of project costs and timelines, via detailed planning, use of tools such as Microsoft Project, and continuous assessment and monitoring against established metrics. Key deliverables from these activities include a project plan, with associated project deliverable milestones, resource usage and schedule details. Documentation: All relevant project documents and deliverables are developed and maintained per industry standards and other relevant guidelines and requirements. Integrated Quality Assurance, Risk Management and Reporting: Quality control and assurance practices are integrated throughout our approach. Examples of such practices include early agreement on Acceptance Criteria. In addition, risk assessment and control practices are included right from the planning stage through the execution and closeout of the project. Key to these practices is the proactive identification, communication, analysis and tracking of risks throughout the project. Also, risk control is an important activity once risks have been identified. The deliverables from this phase include a plan to mitigate cost, schedule and deliverable risk based on the acceptance criteria, as well as project performance reports. We recommend a practical approach that emphasizes a phased approach to process definition, assessment and improvement. Key success factors in implementing process improvement activities include the pro-active involvement of all stakeholders throughout the exercise. It is vital to establish appropriate benchmarks for achieving the optimal improved process. The benchmarking exercise will also allow the selection of specific processes based on their predicted business benefit rather than attempting a huge process change. In addition, it is important to define key metrics to monitor the progress of the improved process. Finally, we recommend continuous training and education as elements of rolling out the improved processes. Page 9 of 9

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